Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Key facts

Study ID

NCT00970268

Run by

AstraZeneca

People needed

291

Starts

2009-08-01

Expected to finish

2010-10-01

Last updated by the study team

2017-01-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of a lead-in study (NCT00891462)

You may not qualify if…

• Use or anticipated use of any medication prohibited in this study
• Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
• The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
• QTcB of >500 msec on both the pre-dose and post-dose ECG
• Women who are pregnant, intend to become pregnant, or are breast-feeding
• A life expectancy of less than 1 year
• Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
• Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Where it is running

• Forest Investigative Site 1127 — Mobile, Alabama, United States
• Forest Investigative Site 0909 — Glendale, Arizona, United States
• Forest Investigative Site 2060 — Phoenix, Arizona, United States
• Forest Investigative Site 2065 — Fullerton, California, United States
• Forest Investigative Site 1088 — Lakewood, California, United States
• Forest Investigative Site 1122 — Orange, California, United States
• Forest Investigative Site 2029 — Rancho Mirage, California, United States
• Forets Investigative Site 2064 — Riverside, California, United States
• Forest Investigative Site 0517 — Sacramento, California, United States
• Forest Investigative Site 2009 — San Diego, California, United States
• Forest Investigative Site 1137 — Colorado Springs, Colorado, United States
• Forest Investigative Site 2100 — Waterbury, Connecticut, United States
• Forest Investigative Site 1154 — Brandon, Florida, United States
• Forest Investigative Site 1152 — Clearwater, Florida, United States
• Forest Investigative Site 0670 — DeLand, Florida, United States
• Forest Investigative Site 0990 — Fort Lauderdale, Florida, United States
• Forest Investigative Site 1167 — Melbourne, Florida, United States
• Forest Investigative Site 1060 — Ormond Beach, Florida, United States
• Forest Investigative Site 0974 — Pensacola, Florida, United States
• Forest Investigative Site 2082 — Tamarac, Florida, United States
• Forest Investigative Site 2053 — Tampa, Florida, United States
• Forest Investigative Site 2047 — Tampa, Florida, United States
• Forest Investigative Site 1185 — Winter Park, Florida, United States
• Forest Investigative Site 1183 — Atlanta, Georgia, United States
• Forest Investigative Site 1162 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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